Hormone Replacement Therapy for Men

Tri-Mix injection requires a prescription from your physician and should be filled only by a pharmacy experienced in sterile compounding, such as Key Compounding Pharmacy.

Approximately 30% of men aged 60-70 years and 70% of men aged 70-80 have low levels of testosterone in forms that the body can use (bioavailable; unbound; free). Hypogonadism is a clinical condition in which low levels of serum testosterone (bioavailable testosterone less than 60 ng/dl) are found in association with specific signs and symptoms, including diminished sex drive and sense of vitality, erectile dysfunction, depression, anemia, reduced muscle mass and bone density, increased fat mass, frailty, and osteoporosis. A man may be considered hypogonadal at any age if total testosterone (bound and free) is less than 200 ng/dl. It is recommended that elderly men with symptoms of hypogonadism and a total testosterone level less than 300 ng/dl be started on hormone replacement.1

When hypogonadism occurs in an older man, the condition is often called andropause, or Androgen Deficiency of the Aging Male (ADAM), because testosterone is in a class of hormones known as androgens. Bioavailable testosterone levels are significantly lower for depressed men, perhaps because an associated decrease in sexual function results in depression, irritability, and mood swings. Testosterone therapy might improve depressed mood in older men who have low levels of bioavailable testosterone.2,3

Osteoporosis-related fractures occur in 12% of all men over 50 years of age. Twenty-five percent of all hip fractures occur in men, and 33% of these patients die within one year of fracture. Gradual loss of testosterone is one of the major causes of osteoporosis in elderly men. Studies have reported beneficial effects of testosterone therapy on bone in older men, showing an increase in bone mineral density (BMD) and slowing of bone degeneration. Testosterone therapy in older men with low serum testosterone levels also increases lean body mass and decreases fat mass, improving physical performance and strength.4

Testosterone replacement therapy (TRT) has relieved symptoms and improved the quality of life for many men. TRT is well tolerated, and long term TRT appears to be a safe and effective means of treating hypogonadal elderly males, provided that laboratory values and clinical response are frequently monitored. The only absolute contraindication to androgen replacement therapy is the presence of prostate or breast cancer. Guidelines recommend that TRT should not be initiated in older men with PSA serum levels above the normal range. Testosterone should be used with caution in men with severe heart, kidney or liver disease, increased red blood cell counts, and sleep apnea.5 Side effects of testosterone therapy can include mood swings, leg swelling, skin reactions, acne, alopecia, breast enlargement, and infertility. Liver toxicity has not been reported following testosterone administration using transdermal gels in physiologic doses.6 (Toxicity has occurred with methyltestosterone.)

Testosterone is well-absorbed from transdermal creams, gels, and lotions. Compounded preparations can be very advantageous because:

the exact amount of hormone needed by each man can be applied as a single dose

there is no need to shave the scrotum to apply one or more patches

there is no skin irritation from patch adhesive.

A healthy lifestyle is associated with higher hormone levels, and higher hormone levels seem to induce a more active, healthier lifestyle. For optimal results, it is vital that hormone replacement therapy be combined with adequate exercise, proper nutrition, and appropriate use of supplements.

References:

Am J Med. 2001 May;110(7):563-72.

J Clin Psychiatry. 2009 Jul;70(7):1009-16.

J Clin Psychopharmacol. 2009 Jun;29(3):216-21.

J Clin Endocrinol Metab. 2005 Mar;90(3):1502-10.

Ther Clin Risk Manag. 2009 Jun;5(3):427-48.

Expert Opin Drug Saf. 2004 Nov;3(6):599-606.

Testosterone vs. Synthetics: What is the Optimal Form of Testosterone for Replacement Therapy?

Testosterone USP is natural bio-identical testosterone that has been approved by the United States Pharmacopoeia and is available as a bulk chemical. Upon a prescription order, compounding pharmacists can use Testosterone USP to prepare numerous dosage forms.

Natural Testosterone Replacement is Central to the Treatment of All Facets of Andropause. The term “testosterone” is often used generically when referring to numerous synthetic derivatives, as well as natural bio-identical testosterone. Confusion is responsible for conflicting data in the medical literature about the benefits and risks of testosterone therapy. Studies must be reviewed carefully to determine the form of testosterone that was used. Natural testosterone must not be confused with synthetic derivatives or “anabolic steroids,” which when used by athletes and body builders have caused disastrous effects. For example, administration of synthetic non-aromatizable androgens, like stanozolol or methyltestosterone, causes profound decreases in HDL-C (“good cholesterol”) and significant increases in LDL-C (“bad cholesterol”). Yet, hormone replacement with aromatizable androgens, such as testosterone, results in lower total cholesterol and LDL cholesterol levels while having little to no impact on serum HDL cholesterol levels. Proper monitoring of laboratory values and clinical response are essential when prescribing testosterone replacement therapy.

The only absolute contraindications to androgen replacement therapy are the presence of prostate or breast cancer. “Although it is known that the clinical course of prostate cancer is accelerated by testosterone, its incidence is not increased by [testosterone] administration… There is even no clear evidence that testosterone replacement accelerates the development of BPH.”

Drugs & Aging 1999 Aug;15(2):131-42

Goals and Therapy

Goals of Testosterone Replacement Therapy in Adult Hypogonadal Men (age 50 or older)

TriMix for Erectile Dysfunction

Erectile Dysfunction (ED; formerly referred to as “impotence”) is estimated to affect 40% of men at age 40, and almost 70% of men at age 70. However, ED has many treatable causes, and does not need to be an inevitable consequence of aging. While treatment with oral medications known as PDE-5 inhibitors (Viagra™, Cialis™, and Levitra™) is very popular, some patients are unable to take these medications because of drug interactions (ie, sildenafil and nitroglycerin) or a lack of response. In addition, these agents can be associated with adverse effects and are not as effective in patients who have undergone radical prostatectomy (removal of prostate) or who have severe vascular disease, which is a common complication of advanced diabetes. Consequently, PDE-5 inhibitor therapy is associated with a high rate of discontinuation.

Self-injection (intracavernosal injection-into shaft of the penis) is a well-accepted and popular therapy for ED from many causes, and is considered “the most effective medical therapy for diabetic erectile dysfunction.” 1 Tri-Mix is a combination of medications (papaverine/phentolamine/prostaglandin) that work in various ways to produce and maintain an erection. Men with ED who used Tri-Mix by self-injection and who changed to oral sildenafil (Viagra™) found they had a greater preference than expected for triple therapy and the erection quality was better with TriMix than with sildenafil.2 Fear of pain with self-injection therapy may discourage some men. Yet, in the majority of ED patients, findings from a Cleveland Clinic study show that discomfort is minimal, which may help to alleviate the fear of injection in those who may benefit from this therapy.3

Early intracavernosal injections following radical prostatectomy facilitated early sexual intercourse, patient satisfaction and potentially earlier return of natural erections, according to a study from the Glickman Urological Institute, Cleveland Clinic Foundation.4 While studies have shown that the highest percentage of positive response in men with erectile dysfunction is achieved with TriMix, the professional compounders at Key Compounding Pharmacy will work together with each patient and his physician to customize doses and combinations of medications to meet specific needs.

Tri-Mix injection requires a prescription from your physician and should be filled only by a pharmacy experienced in sterile compounding, such as Key Compounding Pharmacy.